Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus
This trial is active, not recruiting.
|Condition||type 1 diabetes mellitus|
|Collaborator||William E And Aenid R Weisgerber Foundation|
|Start date||January 2007|
|Trial size||30 participants|
|Trial identifier||NCT00449891, 1102002-100-GHATW, IRB 97517|
This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children and whether there are associated changes on their MRI scan.
Male or female participants from 3 years up to 10 years old.
Inclusion Criteria: Inclusion Criteria for study subjects: - To be between ages 3 to 10 years - Have been diagnosed with type 1 diabetes for at least 6 months; and - Do not have plans to move out of the area within the next 36 months. Inclusion Criteria for control subjects: - To be between ages 3 to 10 years Exclusion Criteria: - No history of head trauma with any loss of consciousness, - Cystic fibrosis, - Prematurity (born less than 30 weeks of gestation), - Significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age), - Neurologic disease independent of diabetes (eg seizure disorder); or - Medical contraindication to MRI procedure (eg metal appliances such as braces).
|Official title||Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus|
|Principal investigator||Tandy Aye, MD|
|Description||In this pilot study approximately 10-20 children between the ages of 3 to 10 years with Type 1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the head performed every three years for three years. We will compare this to a control group of 10 children between the ages of 3 adn 10 years without Type 1 diabetes mellitus. The control subjects will neuropsychological testing and a nonsedated MRI scan of the head once. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen.|
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